Medtronic Spine Clamps Recall: Risk of Spinal Injury from Improper Use
Medtronic recalls spine referencing clamps that may cause spinal injury if damaged during surgery. Learn if your clamps are affected and what to do.
Use caution until it’s fixed
Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
Contact the company
What happened, in plain English
Medtronic is recalling spine clamps used in surgery that could cause injury if damaged during use. This happens if the clamps break and leave parts inside the patient or don't open properly. Read more at govinfonow.com/recall/73499-medtronic-spine-clamps-recall-risk-of-spinal-injury-from-improper.
Source Summary by GovInfoNow · govinfonow.com/recall/73499-medtronic-spine-clamps-recall-risk-of-spinal-injury-from-improper · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3143-2017
Cite this page
“Medtronic Spine Clamps Recall: Risk of Spinal Injury from Improper Use.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73499-medtronic-spine-clamps-recall-risk-of-spinal-injury-from-improper. Based on FDA recall #Z-3143-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3143-2017%22&limit=1).
Why it’s dangerous
The clamps can break when opened beyond their intended limits, either failing to open once attached to the spine or leaving parts inside the patient after breakage. This could cause spinal injury during surgery.
Who’s affected
Surgical teams using Medtronic spine clamps with StealthStation navigation systems during procedures. Patients at risk if clamps break during surgery and leave components inside the body.
How to tell if you have this one
Check for Medtronic spine referencing clamps with part numbers 9734715 or 9734716 used with StealthStation navigation systems. These are for surgical procedures, not consumer products.
- Brand
Medtronic- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania, Australia, Bangladesh, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Kenya, Latvia, Luxembourg, Malaysia, Martinique, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, & Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3139-2017 | Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.; P/N 9734715, 9734715K | 2,051 units total |
| Z-3140-2017 | Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.; P/N 9734716, 9734716K | 2,051 units total |
| Z-3141-2017 | Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.; P/N 9734723, 9734723K | 2051 units |
| Z-3142-2017 | Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.; P/N 9734724, 9734724K | 2,051 units total |
| Z-3143-2017 | Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.; P/N 9734715, 9734716 | 2,051 units total |
What to do — step by step
Check Clamps for Damage
Inspect the clamps for signs of damage or improper opening before use during surgery.
Contact Manufacturer
Reach out to Medtronic for guidance on safe use or if your clamps need replacement.
Where it went and when
Where it was distributed
Distributed in 42 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 6.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3143-2017 (June 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3143-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.